TPLC - Total Product Life Cycle

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Device	device, urine flow rate measuring, non-electrical, disposable
Product Code	FFG
Regulation Number	876.1800
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	180	180
No Flow	92	92
Break	30	30
Leak/Splash	28	28
Obstruction of Flow	22	22
Device Operates Differently Than Expected	21	21
Infusion or Flow Problem	17	17
Occlusion Within Device	17	17
Device Contamination with Chemical or Other Material	13	13
Fluid/Blood Leak	12	12
Defective Device	12	12
Material Separation	9	9
Restricted Flow rate	8	8
Disconnection	7	7
Device Damaged Prior to Use	7	7
Crack	7	7
Detachment Of Device Component	7	7
Sediment, Precipitate Or Deposit In Device Or Device Ingredient	7	7
Fracture	6	6
Material Integrity Problem	6	6
Improper Flow or Infusion	6	6
Partial Blockage	5	5
Delivered as Unsterile Product	5	5
Connection Problem	4	4
Improper Device Output	4	4
Defective Component	3	3
Tear, Rip or Hole in Device Packaging	3	3
Product Quality Problem	3	3
Measurement System Incompatibility	3	3
Biofilm coating in Device	3	3
Contamination /Decontamination Problem	3	3
Collapse	3	3
Insufficient Flow or Under Infusion	2	2
Material Fragmentation	2	2
Unsealed Device Packaging	2	2
Device Packaging Compromised	2	2
Component Missing	2	2
Use of Device Problem	2	2
Unintended Deflation	1	1
Difficult to Open or Close	1	1
Shipping Damage or Problem	1	1
Difficult or Delayed Positioning	1	1
Decoupling	1	1
Contamination	1	1
Device Inoperable	1	1
Positioning Failure	1	1
Out-Of-Box Failure	1	1
Hole In Material	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Contamination With Biological Material	1	1
Device Disinfection Or Sterilization Issue	1	1
Positioning Problem	1	1
Kinked	1	1
Temperature Problem	1	1
Filling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	215	215
No Clinical Signs, Symptoms or Conditions	133	133
No Consequences Or Impact To Patient	89	89
No Patient Involvement	46	46
Urinary Retention	24	24
Insufficient Information	19	19
Missing Value Reason	7	7
Pain	5	5
Tissue Damage	4	4
Rupture	4	4
No Information	4	4
Foreign Body In Patient	4	4
Discomfort	3	3
Obstruction/Occlusion	2	2
Abdominal Distention	2	2
Confusion/ Disorientation	1	1
Dyspnea	1	1
Micturition Urgency	1	1
Urinary Tract Infection	1	1
Burning Sensation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Feb-16-2024